FDA 483 - Octapharma S.A.S. - December 06, 2022

Octapharma S.A.S. in Lingolsheim, France, a biologics blood product manufacturer, received a Form 483 citing numerous significant deficiencies. The inspection revealed inadequate assessment of product impact from discrepancies, failure to follow written procedures, and insufficient employee training. Critical issues also included poor equipment maintenance, unsuitable building design and repair, pervasive pest infestations, and a lack of data integrity controls, indicating a broad breakdown in cGMP compliance.